Recombinant adeno-associated virus (rAAV) vectors have become essential in gene therapy for delivering therapeutic genes effectively. However, the challenge of separating empty capsids from genome-containing particles remains a significant hurdle, impacting product purity, safety, and overall efficacy. Traditional methods, such as density gradient ultracentrifugation, have been widely used but present scalability and consistency issues. Recent developments in anion exchange chromatography (AEX) using weak organic acids provide an innovative solution, allowing efficient separation and enrichment of genome-containing capsids without the limitations of gradient elution. This paper discusses the successful application and scalability of AEX for rAAV purification, offering a promising pathway for large-scale gene therapy manufacturing.
Viralgen, founded in 2017 as a subsidiary of AskBio within the Bayer AG group, is a premier CDMO specializing in AAV-based gene therapies delivering end-to-end support from construct optimization and plasmid DNA production through large-scale clinical and commercial manufacturing. Leveraging the Aava™ manufacturing platform built upon its proprietary Pro10™ suspension cell line, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes, in the world’s largest AAV-dedicated facility, to help clients scale efficiently, optimize cost of goods, and mitigate risk.
Viralgen, founded in 2017 as a subsidiary of AskBio within the Bayer AG group, is a premier CDMO specializing in AAV-based gene therapies delivering end-to-end support from construct optimization and plasmid DNA production through large-scale clinical and commercial manufacturing. Leveraging the Aava™ manufacturing platform built upon its proprietary Pro10™ suspension cell line, Viralgen achieves industry-leading, high-yield, scalable manufacturing across all AAV serotypes, in the world’s largest AAV-dedicated facility, to help clients scale efficiently, optimize cost of goods, and mitigate risk.